{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,10,27]],"date-time":"2025-10-27T05:06:27Z","timestamp":1761541587368,"version":"build-2065373602"},"reference-count":29,"publisher":"Elsevier BV","issue":"4","license":[{"start":{"date-parts":[[2021,4,1]],"date-time":"2021-04-01T00:00:00Z","timestamp":1617235200000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/www.elsevier.com\/tdm\/userlicense\/1.0\/"},{"start":{"date-parts":[[2021,4,1]],"date-time":"2021-04-01T00:00:00Z","timestamp":1617235200000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/www.elsevier.com\/legal\/tdmrep-license"},{"start":{"date-parts":[[2022,11,4]],"date-time":"2022-11-04T00:00:00Z","timestamp":1667520000000},"content-version":"vor","delay-in-days":582,"URL":"http:\/\/www.elsevier.com\/open-access\/userlicense\/1.0\/"}],"content-domain":{"domain":["jthjournal.org","elsevier.com","sciencedirect.com"],"crossmark-restriction":true},"short-container-title":["Journal of Thrombosis and Haemostasis"],"published-print":{"date-parts":[[2021,4]]},"DOI":"10.1111\/jth.15259","type":"journal-article","created":{"date-parts":[[2021,2,6]],"date-time":"2021-02-06T03:12:07Z","timestamp":1612581127000},"page":"967-975","update-policy":"https:\/\/doi.org\/10.1016\/elsevier_cm_policy","source":"Crossref","is-referenced-by-count":9,"title":["Safety, pharmacokinetics, and pharmacodynamics of a next\u2010generation subcutaneously administered coagulation factor IX variant, dalcinonacog alfa, in previously treated hemophilia B patients"],"prefix":"10.1016","volume":"19","author":[{"given":"Chur Woo","family":"You","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Seung\u2010Beom","family":"Hong","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Suyeong","family":"Kim","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ho\u2010Jin","family":"Shin","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8986-8436","authenticated-orcid":false,"given":"Jin Seok","family":"Kim","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jung Woo","family":"Han","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Soo\u2010Jeong","family":"Kim","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Do Young","family":"Kim","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Martin","family":"Lee","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Howard","family":"Levy","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"78","reference":[{"issue":"23","key":"10.1111\/jth.15259_bb0010","doi-asserted-by":"crossref","first-page":"1773","DOI":"10.1056\/NEJM200106073442307","article-title":"The hemophilias\u2013from royal genes to gene therapy","volume":"344","author":"Mannucci","year":"2001","journal-title":"N Engl J Med"},{"issue":"1","key":"10.1111\/jth.15259_bb0015","first-page":"22","article-title":"Bleeding disorders: insights into aetiology, pathogenesis, diagnosis and management","volume":"1","author":"Kabel","year":"2014","journal-title":"Int J Hematol Disord"},{"year":"2015","series-title":"Reference module in biomedical sciences: Hemophilia","author":"Schrader","key":"10.1111\/jth.15259_bb0020"},{"issue":"9","key":"10.1111\/jth.15259_bb0025","doi-asserted-by":"crossref","first-page":"1517","DOI":"10.1517\/14656566.6.9.1517","article-title":"Haemophilia B: Christmas disease","volume":"6","author":"Giangrande","year":"2005","journal-title":"Expert Opin Pharmacother"},{"issue":"4","key":"10.1111\/jth.15259_bb0030","doi-asserted-by":"crossref","first-page":"376","DOI":"10.1046\/j.1365-2516.2003.00764.x","article-title":"Prophylaxis for severe haemophilia: clinical and economical issues","volume":"9","author":"Fischer","year":"2003","journal-title":"Haemophilia"},{"issue":"2","key":"10.1111\/jth.15259_bb0035","first-page":"525","article-title":"Prophylactic infusion regimens in the management of hemophilia","volume":"82","author":"Ljung","year":"1999","journal-title":"Thromb Haemost"},{"issue":"6","key":"10.1111\/jth.15259_bb0040","doi-asserted-by":"crossref","first-page":"535","DOI":"10.1056\/NEJMoa067659","article-title":"Prophylaxis versus episodic treatment to prevent joint disease in boys with severe hemophilia","volume":"357","author":"Manco\u2010Johnson","year":"2007","journal-title":"N Engl J Med"},{"issue":"4","key":"10.1111\/jth.15259_bb0045","doi-asserted-by":"crossref","first-page":"660","DOI":"10.1055\/s-0038-1656030","article-title":"A multicenter study of recombinant factor VIII (Recombinate) in previously treated patients with hemophilia A. The Recombinate Previously Treated Patient Study Group","volume":"77","author":"White","year":"1997","journal-title":"Thromb Haemost"},{"issue":"Suppl 6","key":"10.1111\/jth.15259_bb0050","doi-asserted-by":"crossref","first-page":"13","DOI":"10.1111\/j.1365-2516.2010.02301.x","article-title":"Prophylaxis in haemophilia B patients: unresolved issues and pharmacoeconomic implications","volume":"16","author":"Santagostino","year":"2010","journal-title":"Haemophilia"},{"issue":"Suppl 2","key":"10.1111\/jth.15259_bb0055","doi-asserted-by":"crossref","first-page":"S6","DOI":"10.1016\/S0049-3848(09)70157-4","article-title":"Half\u2010life extension through albumin fusion technologies","volume":"124","author":"Schulte","year":"2009","journal-title":"Thromb Res"},{"key":"10.1111\/jth.15259_bb0060","unstructured":"National Hemophilia Foundation. Fast Facts. https:\/\/www.hemophilia.org\/About\u2010Us\/Fast\u2010Facts. Accessed September 3, 2020."},{"year":"2020","series-title":"BeneFIX\u00ae Coagulation Factor IX (Recombinant) Prescribing Information [Internet]","key":"10.1111\/jth.15259_bb0065"},{"issue":"2","key":"10.1111\/jth.15259_bb0070","doi-asserted-by":"crossref","first-page":"111","DOI":"10.1111\/ejh.13193","article-title":"Inhibitors in haemophilia A and B: management of bleeds, inhibitor eradication and strategies for difficult\u2010to\u2010treat patients","volume":"102","author":"Ljung","year":"2019","journal-title":"Eur J Haematol"},{"issue":"6","key":"10.1111\/jth.15259_bb0075","doi-asserted-by":"crossref","first-page":"578","DOI":"10.1055\/s-0038-1660817","article-title":"Inhibitors in hemophilia B","volume":"44","author":"Santoro","year":"2018","journal-title":"Semin Thromb Hemost"},{"issue":"2","key":"10.1111\/jth.15259_bb0080","doi-asserted-by":"crossref","first-page":"268","DOI":"10.1002\/rth2.12192","article-title":"Favorable pharmacokinetics in hemophilia B for nonacog beta pegol versus recombinant factor IX\u2010Fc fusion protein: a randomized trial","volume":"3","author":"Escuriola Ettingshausen","year":"2019","journal-title":"Res Pract Thromb Haemost"},{"issue":"2","key":"10.1111\/jth.15259_bb0085","doi-asserted-by":"crossref","first-page":"e59","DOI":"10.1016\/S2352-3026(17)30003-0","article-title":"A new, promising, extended half\u2010life rFIX concentrate","volume":"4","author":"Morfini","year":"2017","journal-title":"Lancet Haematol"},{"issue":"22","key":"10.1111\/jth.15259_bb0090","doi-asserted-by":"crossref","first-page":"1389","DOI":"10.1182\/blood.V128.22.1389.1389","article-title":"Pharmacokinetics of subcutaneously administered CB 2679d\/ISU304 in wild\u2010type and hemophilia B mice","volume":"128","author":"Hong","year":"2016","journal-title":"Blood"},{"key":"10.1111\/jth.15259_bb0095","doi-asserted-by":"crossref","first-page":"87","DOI":"10.1182\/blood.V130.Suppl_1.87.87","article-title":"Phase 1\/2 trial of subcutaneously administered factor IX variant CB 2679d\/ISU304: pharmacokinetics and activity","volume":"130","author":"You","year":"2017","journal-title":"Blood"},{"issue":"3","key":"10.1111\/jth.15259_bb0100","doi-asserted-by":"crossref","first-page":"233","DOI":"10.1111\/j.1365-2516.2007.01458.x","article-title":"Reformulated BeneFix: efficacy and safety in previously treated patients with moderately severe to severe haemophilia B [published correction appears in Haemophilia. 2007 Jul; 13(4):450]","volume":"13","author":"Lambert","year":"2007","journal-title":"Haemophilia"},{"key":"10.1111\/jth.15259_bb0105","unstructured":"Blouse GE. A comprehensive in silico and in vitro immunogenicity risk assessment of dalcinonacog alfa shows no increased risk compared with wild\u2010type FIX. Presented at the HDD 2019 meeting \u2013 August 21, 2019. https:\/\/www.catalystbiosciences.com\/file.cfm\/67\/docs\/2019\u201008\u201021\u2010HDD_2019_Blouse.pdf. Accessed November 25, 2020."},{"key":"10.1111\/jth.15259_bb0110","first-page":"745","article-title":"A two\u2010phase linear regression model for biological half\u2010life data","volume":"115","author":"Lee","year":"1990","journal-title":"J Lab Clin Med"},{"key":"10.1111\/jth.15259_bb0115","unstructured":"Idelvion\u00ae Prescribing Information. 2020. https:\/\/labeling.cslbehring.com\/PI\/US\/Idelvion\/EN\/Idelvion\u2010Prescribing\u2010Information.pdf. Accessed November 30, 2020."},{"key":"10.1111\/jth.15259_bb0120","unstructured":"Alprolix\u00ae Prescribing Information. 2020. http:\/\/products.sanofi.us\/Alprolix\/alprolix.html. Accessed November 30, 2020."},{"issue":"1","key":"10.1111\/jth.15259_bb0125","first-page":"201","article-title":"Inhibitor incidence in previously untreated patients with severe haemophilia B: a systematic literature review","volume":"116","author":"Franchini","year":"2016","journal-title":"Thromb Haemost"},{"issue":"2","key":"10.1111\/jth.15259_bb0130","doi-asserted-by":"crossref","first-page":"346","DOI":"10.1111\/hae.13949","article-title":"Activity measurements of dalcinonacog alfa","volume":"26","author":"Williams","year":"2020","journal-title":"Haemophilia"},{"issue":"4","key":"10.1111\/jth.15259_bb0135","doi-asserted-by":"crossref","first-page":"675","DOI":"10.1055\/s-0038-1653839","article-title":"Measurement of activated factor IX in factor IX concentrates: correlation with in vivo thrombogenicity","volume":"73","author":"Gray","year":"1995","journal-title":"Thromb Haemost"},{"issue":"5","key":"10.1111\/jth.15259_bb0140","doi-asserted-by":"crossref","first-page":"602","DOI":"10.1016\/j.transci.2019.08.012","article-title":"Gene therapy for hemophilia: progress to date and challenges moving forward","volume":"58","author":"Gollomp","year":"2019","journal-title":"Transfus Apher Sci"},{"issue":"1","key":"10.1111\/jth.15259_bb0145","doi-asserted-by":"crossref","first-page":"81","DOI":"10.1046\/j.1365-2141.2001.02759.x","article-title":"Haemophilia B mutations in Sweden: a population\u2010based study of mutational heterogeneity","volume":"113","author":"Ljung","year":"2001","journal-title":"Br J Haematol"},{"key":"10.1111\/jth.15259_bb0150","unstructured":"Mahlangu J, Levy H, Negrier C, et al. Phase 2b Trial to Evaluate the Safety & Factor IX Levels Resulting from a Daily Subcutaneous Prophylaxis Treatment Regimen of Dalcinonacog Alfa in HaemophiliaB. 13th Annual Congress of the European Association for Haemophilia Allied Disorders (EAHAD). 7 February 2020: OR07."}],"container-title":["Journal of Thrombosis and Haemostasis"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/jth.15259","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/full-xml\/10.1111\/jth.15259","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/api.elsevier.com\/content\/article\/PII:S1538783622007346?httpAccept=text\/xml","content-type":"text\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/api.elsevier.com\/content\/article\/PII:S1538783622007346?httpAccept=text\/plain","content-type":"text\/plain","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/jth.15259","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,10,27]],"date-time":"2025-10-27T03:32:16Z","timestamp":1761535936000},"score":1,"resource":{"primary":{"URL":"https:\/\/linkinghub.elsevier.com\/retrieve\/pii\/S1538783622007346"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2021,4]]},"references-count":29,"journal-issue":{"issue":"4","published-print":{"date-parts":[[2021,4]]}},"alternative-id":["S1538783622007346"],"URL":"https:\/\/doi.org\/10.1111\/jth.15259","relation":{},"ISSN":["1538-7836"],"issn-type":[{"type":"print","value":"1538-7836"}],"subject":[],"published":{"date-parts":[[2021,4]]},"assertion":[{"value":"Elsevier","name":"publisher","label":"This article is maintained by"},{"value":"Safety, pharmacokinetics, and pharmacodynamics of a next\u2010generation subcutaneously administered coagulation factor IX variant, dalcinonacog alfa, in previously treated hemophilia B patients","name":"articletitle","label":"Article Title"},{"value":"Journal of Thrombosis and Haemostasis","name":"journaltitle","label":"Journal Title"},{"value":"https:\/\/doi.org\/10.1111\/jth.15259","name":"articlelink","label":"CrossRef DOI link to publisher maintained version"},{"value":"article","name":"content_type","label":"Content Type"},{"value":"Copyright \u00a9 2021 International Society on Thrombosis and Haemostasis. Published by Elsevier Inc. All rights reserved.","name":"copyright","label":"Copyright"}]}}